US2012220524A1PendingUtilityA1

Assays for cancer patient monitoring based on levels of analyte components of the plasminogen activator system in body fluid samples

54
Individually held — no corporate assignee on recordPriority: Mar 1, 2002Filed: Feb 28, 2012Published: Aug 30, 2012
Est. expiryMar 1, 2022(expired)· nominal 20-yr term from priority
Inventors:Walter P. CarneyPeter J. Hamer
G01N 2333/8132Y10T436/25G01N 2800/52A61P 35/00G01N 2333/9723G01N 33/86G01N 33/5758
54
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Claims

Abstract

The present invention describes methods of examining, screening over time, and monitoring the outcome of a cancer patient who is undergoing treatment or therapy. More specifically, the invention provides a method of monitoring the progression of disease, or the effectiveness of cancer treatment, in a cancer patient by measuring the levels of one or more analytes of the plasminogen activator (uPA) system, namely, uPA, PAI-1 and the complex of uPA:PAI-1, in a sample taken from the cancer patient, preferably, before treatment, at the start of treatment, and at various time intervals during treatment. An increase or elevation in the levels of one or more of the PA system analytes in the cancer patient compared with the levels one or more of the respective PA system analytes in normal control individuals serves as an indicator of cancer advancement or progression.

Claims

exact text as granted — not AI-modified
1 - 44 . (canceled) 
     
     
         45 . A method of treating a cancer patient with elevated levels of one or more plasminogen activator system components, comprising:
 (a) administering an anticancer therapy to a cancer patient identified to have plasminogen activator inhibitor-1 (PAI-1) or a complex of plasminogen activator and plasminogen activator inhibitor-1 (uPA:PAI-1 complex) at a level in the plasma that is above the cutoff value of PAI-1 or the uPA:PAI-1 complex in the plasma of gender-matched normal controls;   (b) determining if the level of PAI-1 or the uPA:PAI-1 complex in the plasma of the cancer patient is altered following administration of the anticancer therapy, thereby determining if the treatment regimen should be altered; and   (c) administering to the patient an adjusted dosage of the anticancer therapy or a different anticancer therapy if a more aggressive therapy is needed,   thereby treating a cancer patient with elevated levels of one or more plasminogen activator system components.   
     
     
         46 . The method of  claim 45 , wherein the cancer patient has a level of the uPA:PAI-1 complex in the plasma that is above the cutoff value of the uPA:PAI-1 complex in the plasma of gender-matched normal controls. 
     
     
         47 . The method of  claim 45 , wherein the cancer patient has a level of PAI-1 in the plasma that is above the cutoff value of PAI-1 in the plasma of gender-matched normal controls. 
     
     
         48 . The method of  claim 45 , wherein the determining step comprises conducting an assay to measure the plasma level of PAI-1 or the uPA:PAI-1 complex prior to and after administering the anticancer therapy and comparing the plasma level of PAI-1 or the uPA:PAI-1 complex prior to administration of the anticancer therapy with the plasma level of PAI-1 or the uPA:PAI-1 complex after administration of the anticancer therapy. 
     
     
         49 . The method of  claim 45 , wherein the cancer is prostate cancer. 
     
     
         50 . The method of  claim 45 , wherein the cancer is breast cancer. 
     
     
         51 . The method of  claim 45 , wherein the cancer is colon cancer. 
     
     
         52 . The method of  claim 45 , wherein the cancer is lung cancer 
     
     
         53 . The method of  claim 45 , wherein the anticancer therapy is an anti-plasminogen system therapy. 
     
     
         54 . The method of  claim 53 , wherein the anti-plasminogen system therapy is a serine protease inhibitor or uPA receptor antagonist. 
     
     
         55 . The method of  claim 53 , wherein the anti-plasminogen system therapy is a urokinase/plasmin inhibitor. 
     
     
         56 . The method of  claim 45 , further comprising, prior to step (a), measuring the level of PAI-1 or the uPA:PAI-1 complex in a plasma sample from the cancer patient prior to or at the start of cancer treatment or therapy. 
     
     
         57 . The method of  claim 56 , wherein the plasma level of PAI-1 or the uPA:PAI-1 complex is determined by an enzyme linked immunosorbent assay. 
     
     
         58 . The method of  claim 45 , further comprising, prior to step (a), comparing the level of PAI-1 or the uPA:PAI-1 complex in the plasma of the cancer patient to the cutoff value of PAI-1 or the uPA:PAI-1 complex in the plasma of gender-matched normal controls, thereby determining the extent to which the patient's plasminogen activator system components are affected by the cancer. 
     
     
         59 . The method of  claim 45 , further comprising repeating steps (a)-(c). 
     
     
         60 . The method of  claim 45 , wherein the dosage of the anticancer therapy is increased if the level of PAI-1 or the uPA:PAI-1 complex increases. 
     
     
         61 . The method of  claim 45 , wherein the anticancer therapy is changed if the level of PAI-1 or the uPA:PAI-1 complex increases. 
     
     
         62 . The method of  claim 45 , wherein the dosage of the anticancer therapy is decreased if the level of PAI-1 or the uPA:PAI-1 complex decreases. 
     
     
         63 . A method of treating a cancer patient with elevated levels of one or more plasminogen activator system components, comprising:
 (a) administering an anticancer therapy to a cancer patient identified to have urokinase plasminogen activator (uPA) at a level in the serum that is above the cutoff value of uPA in the serum of gender-matched normal controls;   (b) determining if the level of uPA in the serum of the cancer patient is altered following administration of the anticancer therapy, thereby determining if the treatment regimen should be altered; and   (c) administering to the patient an adjusted dosage of the anticancer therapy or a different anticancer therapy if a more aggressive therapy is needed,   thereby treating a cancer patient with elevated levels of one or more plasminogen activator system components.   
     
     
         64 . The method of  claim 63 , wherein the cancer is prostate cancer. 
     
     
         65 . The method of  claim 63 , wherein the cancer is breast cancer. 
     
     
         66 . The method of  claim 63 , wherein the cancer is colon cancer. 
     
     
         67 . The method of  claim 63 , wherein the determining step comprises conducting an assay to measure the serum level of uPA prior to and after administering the anticancer therapy and comparing the serum level of uPA prior to administration of the anticancer therapy with the serum level of uPA after administration of the anticancer therapy. 
     
     
         68 . The method of  claim 63 , wherein the anticancer therapy is an anti-plasminogen system therapy. 
     
     
         69 . The method of  claim 68 , wherein the anti-plasminogen system therapy is a serine protease inhibitor or uPA receptor antagonist. 
     
     
         70 . The method of  claim 68 , wherein the anti-plasminogen system therapy is a urokinase/plasmin inhibitor. 
     
     
         71 . The method of  claim 63 , further comprising, prior to step (a), measuring the level of uPA in a serum sample from the cancer patient prior to or at the start of cancer treatment or therapy. 
     
     
         72 . The method of  claim 71 , wherein the serum level of uPA is determined by an enzyme linked immunosorbent assay. 
     
     
         73 . The method of  claim 63 , further comprising, prior to step (a), comparing the level of uPA in the serum of the cancer patient to the cutoff value of uPA in the serum of gender-matched normal controls, thereby determining the extent to which the patient's plasminogen activator system components are affected by the cancer. 
     
     
         74 . The method of  claim 63 , further comprising repeating steps (a)-(c). 
     
     
         75 . The method of  claim 63 , wherein the dosage of the anticancer therapy is increased if the level of uPA increases. 
     
     
         76 . The method of  claim 63 , wherein the anticancer therapy is changed if the level of uPA increases. 
     
     
         77 . The method of  claim 63 , wherein the dosage of the anticancer therapy is decreased if the level of uPA decreases. 
     
     
         78 . A method of determining the response of a cancer patient to an anticancer therapy, comprising:
 (a) administering an anticancer therapy to a cancer patient identified to have plasminogen activator inhibitor-1 (PAI-1) or a complex of plasminogen activator and plasminogen activator inhibitor-1 (uPA:PAI-1) at a level in the plasma that is above the cutoff value of PAI-1 or the uPA:PAI-1 complex in the plasma of gender-matched normal controls; and   (b) determining if the level of PAI-1 or the uPA:PAI-1 complex is altered,   thereby determining the response of the cancer patient to the anticancer therapy.   
     
     
         79 . The method of  claim 78 , wherein the cancer is prostate cancer. 
     
     
         80 . The method of  claim 78 , wherein the cancer is breast cancer. 
     
     
         81 . The method of  claim 78 , wherein the anticancer therapy is an anti-plasminogen system therapy. 
     
     
         82 . The method of  claim 78 , wherein the determining step comprises conducting an assay to measure the plasma level of PAI-1 or the uPA:PAI-1 complex prior to and after administering the anticancer therapy and comparing the plasma level of PAI-1 or the uPA:PAI-1 complex prior to administration of the anticancer therapy with the plasma level of PAI-1 or the uPA:PAI-1 complex after administration of the anticancer therapy. 
     
     
         83 . A method of determining the response of a cancer patient to an anticancer therapy, comprising:
 (a) administering an anticancer therapy to a cancer patient identified to have urokinase plasminogen activator (uPA) at a level in the serum that is above the cutoff value of uPA in the serum of gender-matched normal controls;   (b) determining if the level of uPA is altered, thereby determining the response of the cancer patient to the anticancer therapy.   
     
     
         84 . The method of  claim 83 , wherein the cancer is prostate cancer. 
     
     
         85 . The method of  claim 83 , wherein the cancer is breast cancer. 
     
     
         86 . The method of  claim 83 , wherein the anticancer therapy is an anti-plasminogen system therapy. 
     
     
         87 . The method of  claim 83 , wherein the determining step comprises conducting an assay to measure the serum level of uPA prior to and after administering the anticancer therapy and comparing the serum level of uPA prior to administration of the anticancer therapy with the serum level of uPA after administration of the anticancer therapy.

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